Index.php?title=Course:SPPH381B/TermProject/Tylenol -Alex Kitt/Blending of Tylenol Ingredients/Dust

Dust poses a significant risk to workers, and can cause numerous health issues outlined in the image below:

In one study of dust in the pharmaceutical industry, values at nine different drug production sites, values of dust ranged from 0.1 to 135 mg/m3. In particular, manual tasks of loading and unloading machinery caused risk of exposure to dust . In one study, 80% of dust measured contained the active ingredient that the workers were working with (corticosteroid), indicating that there was a significant leak in machinery (9). For this reason, the dust produced in the blending process is not only irritating for physical reasons, but also because each component may have inherent chemical risks associated with it.

Batch processing of drugs generally involves taking samples and running tests, such as UV and HPLC, which increases workers exposed to dust .

Controls

Elimination

Instead of producing tablets made from powder, liquid capsules can be produced instead.

Substitution

It may be possible to switch out some of the more hazardous chemicals for less hazardous ones, depending on how necessary they are for the final product. Furthermore, any difference in “particle size, density or shape” will change the type, duration, and speed of blending , which producers may be opposed to as it requires further research.

Engineering Controls

Ventilation: Local exhaust ventilation and general ventilation may prevent dust from spreading

Enclosure of machinery: Use of continuous blending vs batch blending, amongst others, is one way of enclosing system to prevent dust from spreading .

Automated production: Blending can either be done via batch blending or continuous blending. Batch blending involves taking samples during the blending process and running tests such as UV and HPLC, which destroy the product . Batch blending also exposes the worker to dust, as they manually need to take and test samples. Continuous blending, on the other hand, involves process analytical technology (PAT), so that there is no need to take physical samples during the process , for example by using Hyperspectral imaging (HSI) to monitor blending while it occurs . HSI uses near infrared spectroscopy (NIR) to then produces images called 'hypercubes,' which show the development of blending as seen below :

Combining this data from all the ingredients in Tylenol, a graphical representation of mixing can be developed:

The ingredients are considered to be mixed once the graph no longer shows fluctuation.

Additionally, continuous blending eliminates the need to manually weigh and dispense ingredients by using Automatic Dispensing Machines .

Administrative Controls

Monitor dust levels: To ensure dust levels fall below OEL levels, dust levels need to be routinely measured to determine concentrations and if any machinery has a fault.

Wet cleaning: To prevent the spreading of dust during cleaning, 'wet' cleaning can be used. This involves using water to weigh down and stick particles to surfaces, so they cannot become airborne.

Personal Protective Equipment

The suggested PPE involves basic laboratory PPE as well as dust respirators, but higher levels are suggested for large-scale spills :

Safety Glasses: Splash goggles for large spill

Lab Coat: Full suit for large spill

Dust respirator: suggested self-contained breathing apparatus in case of large spill

However, it is noted that “suggested protective clothing might not be sufficient.”